HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS— 510(k) K060127

Name: FDA 510(k) clearance K060127
Creator: U.S. Food and Drug Administration
Published: 2006-03-16

Substantially Equivalent

Arthrosurface, Inc.

FDA 510(k) clearance K060127 for HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS, Substantially Equivalent on 2006-03-16. Applicant: Arthrosurface, Inc.. Device class: 2.

Clearance details

Applicant: Arthrosurface, Inc.
Product code: Code KRR
Device class: Class 2
Regulation: 21 CFR 888.3540
Advisory panel: Orthopedic
Date received: 2006-01-18
Decision date: 2006-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.